PCAST Personalized Medicine Hearing
The Presidents Council of Advisors on Science and Technology held a Personalized Medicine Hearing on January 8, 2008. Here is the testimony of Genelex's CEO, Howard Coleman:
Genelex is a multiply accredited laboratory that has been providing DNA testing for personalizing medicine since 2000. Personalized medicine is usually described as a tool for developing new, tailored treatments. A more immediate opportunity for personalized improvement to healthcare, is comprehensive medication management that puts into action what we already know. Many scientists believe that tens of thousands of lives can be saved every year by programs that takes into account an individual’s genotype and all of the medicines they’re taking.
The most effective DNA tests are of the genes for enzymes responsible for processing approximately one-half of the most commonly prescribed prescription drugs and other medicines. More than half the population have alterations to their DNA that compromise their ability to make these enzymes. These alterations can prevent a drug from working or cause severe adverse side effects.
Many of the DNA tests that Genelex provides are direct to consumers and we believe that people have a fundamental right to learn and control this information. Because of privacy concerns, for example, someone may want to have a DNA test but are not confident that the test results would not fall into the hands of an insurance company or employer if included in their health records.
In addition a gap currently exists between what has been discovered in research laboratories and what is actually put into use. Further restricting access to competently performed tests will increase this gap. Government regulators that might be called on to pass on the efficacy of these tests are obligated to take a conservative point of view, thereby widening the gap between discovery and application. Advocates of restricting this information are concerned that the public may be taken advantage of by unscrupulous and misrepresented tests. Perhaps a way to solve this problem is to develop a rating system that describes the level of proof to which a test has been submitted. In this way people would be provided with a tool to help them decide if a given test met their individual needs.
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